Ameena Jaafar v. HHS - DTaP, infantile spasms (2018)
Case summary [AI summaries can sometimes make mistakes]
Ameena Jaafar filed a petition under the National Childhood Vaccine Injury Act on August 10, 2015, on behalf of her son, A.M., alleging that a diphtheria-tetanus-acellular pertussis (DTaP) vaccine caused infantile spasms. A.M. was born in January 2013 and had an uneventful medical history until his six-month wellness visit on July 22, 2013.
At this visit, he received the DTaP vaccine along with four other vaccines. Approximately two hours later, while shopping at Target, A.M. experienced an episode where his body stiffened, his eyes rolled back, and the area around his lips turned blue.
Ms. Jaafar was advised by a doctor to monitor for further seizure-like activity.
Two days later, on July 24, 2013, Ms. Jaafar took A.M. to the emergency room due to continued seizure-like activity.
No fever was reported during these events. A video electroencephalogram (EEG) performed during the hospitalization confirmed a diagnosis of infantile spasms.
Genetic testing conducted later in 2013 did not identify any known mutations associated with infantile spasms. A.M. underwent treatment for his seizure condition, including anti-seizure medications and dietary changes.
In 2014, A.M. resumed scheduled vaccinations, including DTaP. His anti-seizure medications were decreased and eventually eliminated in March 2014, after which his seizures did not worsen but also did not decrease in frequency or severity.
The parties agreed that A.M.'s subsequent medical history was not relevant to the causation question. Ms.
Jaafar testified that A.M.'s physical development was regular, but his intellectual and behavioral development were delayed, and he received therapies and assistance through an individualized education plan. The case proceeded to a hearing from August 6-8, 2018.
Petitioner's experts were Dr. Maurice Kinsbourne and Dr.
Vera Byers, who proposed a theory that the DTaP vaccine triggered cytokines through a trained innate immune response, causing infantile spasms in a susceptible child. Respondent's experts were Dr.
Stephen McGeady and Dr. Max Wiznitzer, who disputed the proposed immunologic timing and neurologic theory.
Special Master Christian J. Moran issued a bench ruling on August 10, 2018, denying compensation.
He found that respondent's experts were better qualified and more persuasive. The Special Master determined that the episode at Target was itself an infantile spasm, that the two-hour onset was too rapid for the proposed cytokine mechanism, that the medical literature did not support DTaP causing infantile spasms, and that A.M.'s clinical course did not align with the proposed immune theory.
The public decision was issued on September 21, 2018, to make the Special Master's ruling publicly available. Petitioner's counsel was William J.
Melley. Respondent's counsel included Debra A.
Filteau Begley and Mollie D. Gorney.
Theory of causation
Petitioner Ameena Jaafar alleged that the DTaP vaccine administered on July 22, 2013, to her six-month-old son, A.M., caused infantile spasms that began approximately two hours later. Petitioner's experts, Dr. Maurice Kinsbourne and Dr. Vera Byers, proposed a theory that the DTaP vaccine triggered a trained innate immune response, leading to cytokine release and causing infantile spasms in a susceptible child. Respondent's experts, Dr. Stephen McGeady and Dr. Max Wiznitzer, contested this theory. Special Master Christian J. Moran denied compensation on August 10, 2018, finding that the petitioner failed to meet her burden of proof under the Althen standard. The Special Master found the respondent's experts to be more qualified and persuasive. Key evidence included a video EEG confirming infantile spasms, the absence of fever with the events, negative genetic testing for known infantile spasm mutations, and A.M.'s subsequent DTaP vaccination without worsening of seizures. The Special Master determined that the two-hour onset was incompatible with the proposed cytokine mechanism, that no reliable theory linked DTaP to infantile spasms, and that A.M.'s clinical course did not support the proposed immune theory. The Special Master also noted the lack of treating physician support for the petitioner's theory and the failure to establish a logical sequence of cause and effect. No award was made. Petitioner's counsel was William J. Melley; respondent's counsel included Debra A. Filteau Begley and Mollie D. Gorney.
Source PDFs
USCOURTS-cofc-1_15-vv-00267